Use of EMG to Assess Clinical Hypertonia - Full Text View

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00472914

Purpose

A handheld surface electromyography device will be tested by clinicians on children with limb hypertonia, and inter-rater reliability will be assessed with and without the device.

Condition	Intervention	Phase
Cerebral Palsy Hypertonia Spasticity Dystonia Rigidity	Device: portable surface electromyography	Phase I Phase II

Genetics Home Reference related topics: early-onset primary dystonia

MedlinePlus related topics: Cerebral Palsy Dystonia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title:	Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children

Further study details as provided by Stanford University:

Estimated Enrollment:	14
Study Start Date:	January 2007
Study Completion Date:	March 2007

Detailed Description:

Hypothesis:

Qualitative surface EMG measurement during passive movement will increase the inter-rater reliability of clinicians for diagnosis of spasticity and dystonia in children with hypertonia.

Specific Aims:

Develop a handheld surface EMG device with auditory output that can be used similarly to a stethoscope to listen non-invasively to the activity of muscles.
Provide clinicians at 5 different institutions with a device to test for 2 months in their own clinics.
Bring all 5 clinicians to Stanford University for a single-day exercise in which each clinician will examine 10 children with hypertonia. Each clinician will rate the children without using the device, and then again with the device. Intra-class correlations and kappa statistics will be used to assess whether the use of the device leads to improved inter-rater reliability.

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 6-18
hypertonia in at least one limb due to spasticity

Exclusion Criteria:

any condition that would increase the risk of participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472914

Locations

United States, California
Stanford University
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Terence D Sanger, Md, PhD

Stanford University

More Information

Study ID Numbers:	EMG auditory
Study First Received:	May 11, 2007
Last Updated:	May 11, 2007
ClinicalTrials.gov Identifier:	NCT00472914
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:

Hypertonia
Childhood

Study placed in the following topic categories:

Dystonic Disorders
Brain Damage, Chronic
Muscle Rigidity
Dystonia
Central Nervous System Diseases
Brain Diseases
Dyskinesias

Paralysis
Signs and Symptoms
Muscle Spasticity
Cerebral Palsy
Muscle Hypertonia
Neurologic Manifestations
Brain Injuries

Additional relevant MeSH terms:

Neuromuscular Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009